FDA approves Astex MDS combo

July 7, 2020

The U.S. Food and Drug Administration has approved an oral combination of decitabine and cedazuridine for adult patients with myelodysplastic syndromes (MDS). This includes previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes: refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts and chronic myelomonocytic leukemia [CMML]). Intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups are included as well.

Astex Pharmaceuticals' Inqovi (cedazuridine) was investigated in two open-label, randomized, crossover trials. Inqovi is taken as one tablet by mouth once daily for five consecutive days of each 28-day cycle. The clinical trial showed similar drug concentrations between intravenous decitabine and Inqovi. About half of the patients who were formerly dependent on transfusions were able to no longer require transfusions during an 8-week period. The safety profile of Inqovi was also similar to intravenous decitabine.

The FDA granted this application Priority Review. This review also used the Oncology Center of Excellence Assessment Aid and the Office of Pharmaceutical Quality’s Assessment Aid. The FDA collaborated with international agency counterparts on the review of this application as part of Project Orbis.

Read the FDA release